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pivekimab sunirine   Click here for help

GtoPdb Ligand ID: 14543

Synonyms: Decnupaz® | IMGN 632 | IMGN-632 | IMGN632 | pivekimab sunirine-pvzy | PVEK [2]
Approved drug
pivekimab sunirine is an approved drug
Compound class: Antibody
Comment: Pivekimab sunirine (IMGN632) is an interleukin 3 receptor subunit alpha (IL3RA) antibody-drug conjugate [2,4]. The payload is a DNA mono-alkylating compound (a monoamine indolinobenzodiazepine pseudodimer) [1]. The antibody is intended to deliver the toxic conjugate to neoplastic blood cells that overexpress IL3RA [5-6].
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Summary of Clinical Use Click here for help
Pivekimab sunirine (IMGN-632) was progressed as a clinical candidate for the treatment of IL3RA (CD123)-overexpressing haematological malignancies. It was granted FDA orphan drug designations for the treatment of acute myeloid leukemia (AML; 2018) and blastic plasmacytoid dendritic cell neoplasm (BPDCN; 2020). The FDA approved pivekimab sunirine in May 2-26, to treat BPDCN.
Clinical Trials
Clinical Trial ID Title Type Source Comment References
NCT03386513 Study of IMGN632 in Patients With Untreated BPDCN and Relapsed/Refractory BPDCN Phase 1/Phase 2 Interventional AbbVie The CADENZA study 3
NCT06034470 Combination Chemotherapy (FLAG-Ida) With Pivekimab Sunirine (PVEK) for the Treatment of Newly Diagnosed Adverse Risk Acute Myeloid Leukemia and Other High-Grade Myeloid Neoplasms Phase 1 Interventional Fred Hutchinson Cancer Center
NCT04086264 IMGN632 as Monotherapy or With Venetoclax and/or Azacitidine for Participants With CD123-Positive Acute Myeloid Leukemia Phase 1/Phase 2 Interventional AbbVie